Informations générales (source: ClinicalTrials.gov)
A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, and Efficacy of AZD3470, a PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agent(s) in Participants With Relapsed/Refractory Haematologic Malignancies
Interventional
Phase 1/Phase 2
AstraZeneca (Voir sur ClinicalTrials)
janvier 2024
mai 2026
27 août 2025
This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy
following oral administration of AZD3470 as a monotherapy, and in combination with other
anticancer agents in participants with haematologic malignancies.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Vincent RIBRAG | 16/04/2026 18:15:08 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69310 - Pierre Benite - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94805 - Villejuif Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion criteria
- Adequate organ and bone marrow function.
- In Part A (dose escalation), participants must be aged ≥ 18 years at the time of
signing the informed consent. In Part B (dose optimization/expansion), participants
must be at least 15 years of age.
- Histologically confirmed documented diagnosis of r/r cHL based on criteria
established by the World Health Organization
- Must provide FFPE baseline tumour tissue to meet the minimum tissue requirement for
central MTAP expression determination.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Contraceptive use by males or females should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Module 1 (cHL):
- At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion > 1.5 cm.
- Participants must have documented r/r active disease, must have previously received
at least 3 prior lines of therapy (including Brentuximab Vedotin and anti-PD-1
therapy) for the treatment of cHL, and must have exhausted all available therapies
with demonstrated clinical benefit.
Exclusion criteria
- Any significant laboratory finding or any severe and uncontrolled medical condition.
- Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord
compression.
- Serologic active HBV or HCV infection.
- Known to have tested positive for HIV.
- Active gastrointestinal disease or other condition that will interfere with oral
therapy.
- Any of the following cardiac criteria:
- Mean resting QTcF > 470 msec or clinically important abnormalities in rhythm
(ventricular arrhythmias and uncontrolled atrial fibrillation)
- Factors that increase the risk of QTc prolongation or risk of arrhythmic events
- Cardiac procedures or conditions within the last 6 months: Coronary artery
bypass graft (CABG), percutaneous coronary intervention (PCI) or heart valve
intervention vascular stent implantation, acute coronary syndrome / myocardial
infarction, uncontrolled angina pectoris, use of therapeutic anti-coagulation
for treatment of active thromboembolic events.
- Severe valvular heart disease
- Congestive heart failure Grade II to Grade IV
- Prior or current cardiomyopathy
- Uncontrolled hypertension
- Brain perfusion problems such as haemorrhagic or thrombotic stroke (including
transient ischemic attacks)
- Unresolved non-haematological toxicities of Grade > 1 from prior anticancer therapy
(excluding peripheral neuropathy, vitiligo, alopecia, and endocrine disorders that
are controlled with replacement hormone therapy, and asymptomatic laboratory
abnormalities), unless immune-mediated.
- History of another primary malignancy.
- History of significant haemoptysis or haemorrhage within 4 weeks of the first dose
of study treatment.
- Requires ongoing immunosuppressive therapy, including systemic corticosteroids.
- Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
- Adequate organ and bone marrow function.
- In Part A (dose escalation), participants must be aged ≥ 18 years at the time of
signing the informed consent. In Part B (dose optimization/expansion), participants
must be at least 15 years of age.
- Histologically confirmed documented diagnosis of r/r cHL based on criteria
established by the World Health Organization
- Must provide FFPE baseline tumour tissue to meet the minimum tissue requirement for
central MTAP expression determination.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Contraceptive use by males or females should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
Module 1 (cHL):
- At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion > 1.5 cm.
- Participants must have documented r/r active disease, must have previously received
at least 3 prior lines of therapy (including Brentuximab Vedotin and anti-PD-1
therapy) for the treatment of cHL, and must have exhausted all available therapies
with demonstrated clinical benefit.
Exclusion criteria
- Any significant laboratory finding or any severe and uncontrolled medical condition.
- Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord
compression.
- Serologic active HBV or HCV infection.
- Known to have tested positive for HIV.
- Active gastrointestinal disease or other condition that will interfere with oral
therapy.
- Any of the following cardiac criteria:
- Mean resting QTcF > 470 msec or clinically important abnormalities in rhythm
(ventricular arrhythmias and uncontrolled atrial fibrillation)
- Factors that increase the risk of QTc prolongation or risk of arrhythmic events
- Cardiac procedures or conditions within the last 6 months: Coronary artery
bypass graft (CABG), percutaneous coronary intervention (PCI) or heart valve
intervention vascular stent implantation, acute coronary syndrome / myocardial
infarction, uncontrolled angina pectoris, use of therapeutic anti-coagulation
for treatment of active thromboembolic events.
- Severe valvular heart disease
- Congestive heart failure Grade II to Grade IV
- Prior or current cardiomyopathy
- Uncontrolled hypertension
- Brain perfusion problems such as haemorrhagic or thrombotic stroke (including
transient ischemic attacks)
- Unresolved non-haematological toxicities of Grade > 1 from prior anticancer therapy
(excluding peripheral neuropathy, vitiligo, alopecia, and endocrine disorders that
are controlled with replacement hormone therapy, and asymptomatic laboratory
abnormalities), unless immune-mediated.
- History of another primary malignancy.
- History of significant haemoptysis or haemorrhage within 4 weeks of the first dose
of study treatment.
- Requires ongoing immunosuppressive therapy, including systemic corticosteroids.
- Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.